510(k) K163228
K163228 is an FDA 510(k) premarket notification submitted by Aesthetic-Press, LLC for the device "APVolution System". The FDA issued a decision of Substantially Equivalent on Jun 5, 2017. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 5, 2017
- Date Received
- Nov 17, 2016
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powder, Porcelain
- Device Class
- Class II
- Regulation Number
- 872.6660
- Review Panel
- DE
- Submission Type
- 510(k)